VAXCHORA Pediatric Study

Inclusion Criteria:

- Male or Female

- Between 2 and <18 years of age on Day 1

- In general good health

- Able and willing to provide informed assent for study participation

- Primary caregiver is able and willing to provide informed consent for study
participation

- (for females of childbearing potential) Using an acceptable method of contraception
through Day 29

Exclusion Criteria:

- Current acute gastrointestinal illness or loose stools within 3 days of Day 1 visit

- Current acute febrile illness

- History of cholera infection

- History of cholera vaccination

- History of severe allergic reaction (e.g. anaphylaxis) to any ingredient of VAXCHORA

- Congenital or acquired immunodeficiency

- Pregnancy (for females of childbearing potential)

- Any other condition that, in the opinion of the Investigator, creates an unacceptable
risk to the subject

- Any other condition that, in the opinion of the Investigator, will interfere with the
conduct of the study or the validity of the data

- Duration of >2 weeks of abnormal stool pattern, defined as <3 stools per week or >2
stools per day in the past 6 months

- Regular use of laxatives in the past 6 months

- History of enterotoxigenic E. coli infection

- Travel to cholera-endemic area in the previous 5 years

- Nursing/Breastfeeding

- Received or plans to receive the following from 14 days prior to the study vaccination
through 11 days after vaccination: Any other licensed vaccines, antibiotics, or
chloroquine

- Received or plans to receive any other investigational agent throughout the main study
(Day 181)